NCT00265356

Brief Summary

The purpose of this trial is to improve the management of patients with potentially surgically curable colorectal cancer liver metastases. The primary objective is to determine the impact of pre-operative positron emission tomography (PET) on patients who have been assessed as having resectable colorectal cancer liver metastases by conventional imaging (computed tomography (CT) abdomen/thorax, colonoscopy), by determining the proportion of patients who have a change in management resulting from PET.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
404

participants targeted

Target at P50-P75 for phase_3 colorectal-cancer

Timeline
Completed

Started Nov 2005

Typical duration for phase_3 colorectal-cancer

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 12, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2005

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

October 21, 2013

Status Verified

October 1, 2013

Enrollment Period

4.4 years

First QC Date

December 12, 2005

Last Update Submit

October 18, 2013

Conditions

Colorectal CancerLiver Metastases

Keywords

Positron Emission Tomography (PET)Diagnostic InvestigationColorectal cancerLiver metastasesLiver surgery

Outcome Measures

Primary Outcomes (1)

  • proportion of patients who have a change in management resulting from PET

    12 months

Secondary Outcomes (6)

  • proportion of patients precluded from having a liver resection because of additional metastatic disease identified on PET

    12 months

  • 3-year overall survival of patients who undergo surgery with curative intent

    12 months

  • 3-year overall survival of all patients

    12 months

  • sensitivity and specificity of PET in detecting other hepatic and extra-hepatic metastatic disease prior to a potentially curable liver resection for colorectal adenocarcinoma metastatic disease

    12 months

  • economic analysis of the addition of PET in the diagnostic work-up

    4 year

  • +1 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

PET diagnostic imaging

Procedure: PET diagnostic imaging

2

NO INTERVENTION

No PET

Interventions

PET diagnostic imagingPROCEDURE

PET diagnostic imaging

Also known as: Positron Emission Tomography
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologic proof of previous colorectal adenocarcinoma (not carcinoid, squamous cell cancer, gastrointestinal stromal tumor, or lymphoma)
  • Contrast-enhanced spiral CT scan of the thorax, and a tri-phasic CT scan of the abdomen and pelvis performed within 30 days (plus up to 14 days) before randomization demonstrating resectable metastasis(es) that are isolated to the liver
  • Full colonoscopy performed within the preceding 18 months showing no evidence of malignancy (other than a synchronous colorectal primary expected to be removed at time of liver resection)
  • Age over 18 years

You may not qualify if:

  • Extrahepatic disease including enlarged portal lymph nodes on CT
  • Prior liver resection
  • Previous radiofrequency ablation of malignant liver lesion
  • Systemic chemotherapy within three weeks prior to randomization
  • Radiotherapy within two months prior to randomization
  • Significant concurrent medical problems (e.g., uncontrolled diabetes, active cardiac disease, significant chronic obstructive pulmonary disease) making the patient unfit for surgery
  • Pregnant or lactating female
  • Unable to lie supine for imaging with PET
  • Previously treated cancer other than non-melanocytic skin cancer or carcinoma in situ of the cervix, unless disease-free for 5 years or greater
  • Patients who, at the time of the initial evaluation, have already undergone a whole body PET within 6 months prior to randomization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Hamilton Health Sciences

Hamilton, Ontario, L8N 3Z5, Canada

Location

St. Joseph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

Location

Cancer Centre of Southeastern Ontario at Kingston General Hospital

Kingston, Ontario, K7L 5P9, Canada

Location

Grand River Regional Cancer Centre

Kitchener, Ontario, N2G 1G3, Canada

Location

London Health Sciences

London, Ontario, N6A 5A5, Canada

Location

The Ottawa Hospital Regional Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Location

Toronto Sunnybrook Regional Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

University Health Network

Toronto, Ontario, M5G 1X5, Canada

Location

St. Joseph's Health Centre

Toronto, Ontario, M6R 1B5, Canada

Location

Related Publications (2)

  • Serrano PE, Gafni A, Gu CS, Gulenchyn KY, Julian JA, Law C, Hendler AL, Moulton CA, Gallinger S, Levine MN. Positron Emission Tomography-Computed Tomography (PET-CT) Versus No PET-CT in the Management of Potentially Resectable Colorectal Cancer Liver Metastases: Cost Implications of a Randomized Controlled Trial. J Oncol Pract. 2016 Jul;12(7):e765-74. doi: 10.1200/JOP.2016.011676. Epub 2016 Jun 21.

    PMID: 27328792DERIVED

  • Moulton CA, Gu CS, Law CH, Tandan VR, Hart R, Quan D, Fairfull Smith RJ, Jalink DW, Husien M, Serrano PE, Hendler AL, Haider MA, Ruo L, Gulenchyn KY, Finch T, Julian JA, Levine MN, Gallinger S. Effect of PET before liver resection on surgical management for colorectal adenocarcinoma metastases: a randomized clinical trial. JAMA. 2014 May 14;311(18):1863-9. doi: 10.1001/jama.2014.3740.

    PMID: 24825641DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Steven Gallinger, MD

    University Health Network: Mount Sinai Hospital

    STUDY CHAIR

  • Mark Levine, MD

    Ontario Clinical Oncology Group (OCOG)

    PRINCIPAL INVESTIGATOR

  • Carol-anne Moulton, MD

    University Health Network: Toronto General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2005

First Posted

December 14, 2005

Study Start

November 1, 2005

Primary Completion

April 1, 2010

Study Completion

April 1, 2013

Last Updated

October 21, 2013

Record last verified: 2013-10

Locations

CA(9)